Alerta De Seguridad para SURGICAL GLOVE (Anvisa Record: 80105840005) - Supermax Glove - Malaysia ;. GLOVE FOR NON-SURGICAL PROCEDURE WITH POWDER - (Anvisa Record: 80105840002) - Supermax Glove - Malaysia; GLOVE FOR NON-PULP SURGICAL PROCEDURE - (Anvisa Record: 80105840003) - Maxter Glove - Malaysia;

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Supermax Brasil Importadora S/A..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1039
  • Fecha
    2010-12-23
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notas adicionales en la data
    According to DRC 05 of February 15, 2008, surgical gloves and gloves of non-surgical procedures of natural rubber, synthetic rubber or mixture of natural and synthetic rubbers, under sanitary surveillance regime, must meet the conformity certification requirements in the scope of the Brazilian Conformity Assessment System (SBAC). ##### UPDATE - 02/14/2011 - Regularization of the situation of the company next to the IFBQ, resuming the use of the Seal of Identification of Compliance referring to the GLOVE FOR NON-PULP SURGICAL PROCEDURE - (Registro Anvisa: 80105840003) - Maxter Glove - Malaysia, and can be marketed normally. Ref. 526/2011 - IFBQ. ##### UPDATE 04/04/2011 - Regularization of the situation of the company next to the IFBQ, resuming the use of the Conformity Identification Seal referring to the GLOVE FOR NON-PULP SURGICAL PROCEDURE PP Size - (Anvisa Record: 80105840003) - Supermax Glove - Malaysia, and can be marketed normally. Ref. 1000/2011 - IFBQ.
  • Causa
    Suspension of the authorization for the use of the seal of conformity identification, made by the falcão bauer institute of quality.
  • Acción
    -

Manufacturer